BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PLANNER, SIGNATURE GUIDES

    MDR report key: 3975891 · Received July 21, 2014

    Report

    Report Number
    3003998208-2014-00007
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    January 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MATERIALISE N.V.
    Product Code
    HRY
    PMA / PMN Number
    K110415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION IS IN PROGRESS WHICH HAS NOT YET RESULTED ON A ROOT CAUSE FOR THE EVENT. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED AS SOON AS THE INVESTIGATION IS TERMINATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND SUBSEQUENTLY WAS REVISED (B)(6) 2014. IT WAS REPORTED THE PATIENT EXPERIENCED DISLOCATION AFTER THE FIRST SURGERY DUE TO THE FEMORAL AND TIBIAL COMPONENTS NOT ALIGNING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426346 SIGNATURE PLANNER, SIGNATURE GUIDES KNEE PROSTHESIS HRY MATERIALISE N.V. 42-411560 94525

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention